Using a clinical trial schedule of assessments (SOA) as a quality improvement tool.
Authors: Varun Paul, Lori Ferranti, David M. Dilts
Journal: Journal of Clinical Oncology (2022)

e18638 Background: The SOA is a key part of any clinical trial as it highlights activities to be performed during trial execution. Such a schedule provides a roadmap and calendar of tests, measurements, and evaluations. Normally, such a schedule is created after a protocol has been mostly created. Our aim is to demonstrate that the SOA can have a broader usage: that of a quality improvement (QI) tool used during protocol creation, thus helping to ensure a high-quality protocol at the design. When creating a protocol conflicting uses of the Protocol contribute to operational tension. For example, Trial Operations, which wishes to minimize the complexity of the trial, may debate with Clinical Science, who wish to collect the greatest amount of scientific tests and data. The more complex a set of requirements in the protocol, there is a corresponding drop in available sites able to meet those needs. Additionally potential sites may comment about being burdened with tests that are unnecessary to the core protocol aims, thus creating unnecessary delays in the trial. All these issues may be addressed by using the SOA as a QI tool. Methods: This research was completed at a major, international pharmaceutical organization for a Phase III oncology clinical trial. A team was created composed of: Clinical Scientist Lead , Stats/Data Lead, Trial Operations Led, Medical Monitor, Medical Leader, and Lean Expert. Methodologically, this was led by the Lean Expert and each team member was sent an electronic version of a draft SOA for review. They inserted questions and comments that were visible to the entire team. After this, an SOA issues log was created in an SOA tracking system. This system categorized and ranked issues for discussion by the entire team during the creation process of both the SOA and the protocol. The process used a “House of Quality” framework, allowing for the aggregation of protocol requirements so that they could be addressed in total, rather than individually. Results: The process was successful in 3 critical dimensions. From a time metric, the SOA was produced 3 to 6 months faster, enabling numerous efficiencies such as providing the development team with information both faster and at the time the team was creating the final protocol. Second, from an economic standpoint, the labor efficiency of the trial was improved as it required 33% less individuals to produce the SOA and protocol resulting in a protocol at record speed. Finally, protocol quality was increased as in this method the team worked jointly together, nearly simultaneously, to complete both the SOA and the protocol. This reduced the number of Protocol Amendments by 50%. Conclusions: Using this method, there was an increase in quality, a reduction in cost, and a faster time to the sites. This reduced the commercialization timeline by 3-6 months which is a significant cost savings. But most importantly, this allows for better treatment faster to be in the hands of oncologists to treat patients.